DRKS00032408招募中Unknown
Improving rates of remission by using a digital health app for triaging patients with axial spondyloarthritis and high disease activity to subsequently adapt medication (DATAX) - DATAX
St. Elisabeth Gruppe GmbH0 个研究点目标入组 330 人开始时间: 2024年2月7日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Diagnosis of axSpA according to their rheumatologist
- •High disease activity defined as BASDAI = 4
- •Treatment initiation with continuous NSAIDs (nonsteroidal anti-inflammatory drug) medication is planned
- •bDMARD-naïve
- •Willingness to adhere to the study intervention, especially willigness to document disease activity measures frequently
- •Willingness of the patient to use their own smartphone to install (to download the app from the app stores: Apple’s App Store or Google’s Play Store on their mobile device) the RheCORD app and for documentation of disease activity
排除标准
- •Patient received two full courses of NSAIDs at a daily full dose for at least 2 weeks each
- •have contraindications to NSAIDs
- •taking high potency opioid analgesics (e.g. methadone)
- •comorbidities which cause back pain or might confound initiation and evaluation of the treatment response, such as fibromyalgia
- •concurrent liver disease (ALT >2 times upper limit of normal)
- •renal disease (creatinine clearance <30 ml/minute)
- •Any medical condition that would preclude the participant from adhering to the protocol
- •Insufficient knowledge of the German language
研究者
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